Status Approved
First Submitted Date
2018/11/04
Registered Date
2019/03/25
Last Updated Date
2019/02/25
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003663 |
---|---|
Unique Protocol ID | WKUH 2018-02-054 |
Public/Brief Title | Effect of cardiac rehabilitation after myocardial infarction |
Scientific Title | Effect of cardiac rehabilitation on cardiorespiratory fitness and adherent factors after percutaneous coronary intervention |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
---|---|
Board Approval Number | WKUH 2018-02-054 |
Approval Date | 2018-04-05 |
Institutional Review Board Name | Wonkwang University Hospital Institutional Review Board |
Institutional Review Board Address | 895, Muwang-ro, Iksan-si, Jeollabuk-do |
Institutional Review Board Telephone | 063-859-2232 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | MINSU KIM |
Title | Doctor |
Telephone | +82-63-859-1610 |
Affiliation | Wonkwang University Hospital |
Address | 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea |
Contact Person for Public Queries | |
Name | MINSU KIM |
Title | Doctor |
Telephone | +82-63-859-1610 |
Affiliation | Wonkwang University Hospital |
Address | 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea |
Contact Person for Updating Information | |
Name | MINSU KIM |
Title | Doctor |
Telephone | +82-63-859-1610 |
Affiliation | Wonkwang University Hospital |
Address | 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea |
4. Status
Study Site | Single | |
---|---|---|
Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-04-09 Actual | |
Target Number of Participant | 44 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Wonkwang University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-04-09 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Wonkwang University Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Wonkwang University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Coronary heart disease (CHD) is one of the leading causes of death worldwide, accounting for one third of all deaths. Cardiac rehabilitation decreases cardiac and all-cause mortality and reduces cardiovascular risk factors. In addition, cardiac rehabilitation in patients with myocardial infarction is known to significantly improve the cardiopulmonary function and exercise capacity, improve quality of life, and promote social functioning. Therefore, cardiac rehabilitation is an important support program for the recovery and secondary prevention of coronary heart disease. Both the American College of Cardiology and the European Society of Cardiology advocate CR for patients after percutaneous coronary intervention (PCI) or coronary artery bypass grafting. However, despite the benefits of cardiac rehabilitation, the rate of enrollment in cardiac rehabilitation programs around the world remains suboptimal from 20% to 30%, and there are many patients who give up even if they participate in cardiac rehabilitation once. In previous research about participation rates of cardiac rehabilitation, various barriers to cardiac rehabilitation have been identified, such as the lack of awareness of cardiac rehabilitation, time constraints, and inaccessibility. In addition, it was reported that participation rate was low in women, elderly, unemployed, and low educated people. Researches of referral, enrollment rates, and factors affecting participation are essential to increase cardiac rehabilitation participation rates. However, data on enrollment of Asian patients in CR are very limited. Meanwhile, a number of studies have documented improvements in functional capacity after cardiac rehabilitation programs in patients with myocardial infarction who were subjected to percutaneous coronary intervention (PCI). Previous studies have reported increase in peak VO2, in the range of 14% to 31% after exercise training. In other studies, exercise tolerance and peak workload were significantly improved after 3 weeks of cardiac rehabilitation, as well as peak VO2, peak VCO2, and peak ventilatory exchange. However, studies about the effect of cardiac rehabilitation on cardiopulmonary function have been rarely reported in Korea. Understanding of referral, participation patterns of patients, and the barrier to participation are essential to improving access to cardiac rehabilitation. In addition, the effect of cardiac rehabilitation on the improvement of cardiopulmonary function in patients with myocardial infarction has not yet been studied in Korea. In this study, we analyzed the data of the patients diagnosed with acute myocardial infarction undergoing percutaneous coronary intervention and examine the factors involved in cardiac rehabilitation participation and the effects of cardiac rehabilitation on cardiorespiratory function. |
---|
8. Study Design
Study Type | Interventional Study |
---|---|
Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Open |
Allocation | Non-RCT |
Intervention Type | Others (rehabilitation therapy) |
Intervention Description | The subjects who were diagnosed as acute myocardial infarction and underwent percutaneous coronary intervention were divided into those who participated in cardiac rehabilitation and those who did not. Those participating in cardiac rehabilitation should perform one hour of aerobic exercise training per session, three times a week for six weeks. |
Number of Arms | 2 |
Arm 1 |
Arm Label Cardiac rehabilitation group |
Target Number of Participant 22 |
|
Arm Type Experimental |
|
Arm Description CR group perform one hour of aerobic exercise training per session, three times a week for six weeks. Each session consists of 10 minutes of warm-up, 15 minutes of main exercise, 5 minutes of resting exercise, 15 minutes of main exercise and 10 minutes of cool-down. The intensity of the exercise is 60-80% of VO2max. Exercise tolerance test (ETT) is performed at baseline, 3month, and 6 month. |
|
Arm 2 |
Arm Label Control group |
Target Number of Participant 22 |
|
Arm Type No intervention |
|
Arm Description The control group did not participate cardiac rehabilitation, and regular follow up was performed through the outpatient clinic. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (I00-I99)Diseases of the circulatory system (I25.1)Atherosclerotic heart disease Cardiac Rehabilitation, Myocardial Infarction, Percutaneous Coronary Intervention |
---|---|
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 30Year~80Year |
|
Description 1)In our institution, patients who were diagnosed as acute myocardial infarction and underwent percutaneous coronary intervention 2)Those who performed the first exercise testing based on treadmill (ETT) evaluation after discharge |
|
Exclusion Criteria |
1)A person with a medical condition who may be disturbed in the clinical research due to severe or unstable physical illness at the time of selection 2)Those who refused participation in cardiac rehabilitation and did not perform ETT evaluation. |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Maximal oxygen consumption (VO2max) |
|
Timepoint | Baseline(Within 2 weeks after discharge), 3month, 6month |
|
Secondary Outcome(s) 1 | ||
Outcome | Blood pressure |
|
Timepoint | Baseline(Within 2 weeks after discharge), 3month, 6month |
|
Secondary Outcome(s) 2 | ||
Outcome | Heart rate |
|
Timepoint | Baseline(Within 2 weeks after discharge), 3month, 6month |
|
Secondary Outcome(s) 3 | ||
Outcome | Ventilatory threshold |
|
Timepoint | Baseline(Within 2 weeks after discharge), 3month, 6month |
|
Secondary Outcome(s) 4 | ||
Outcome | Maximal ventilation |
|
Timepoint | Baseline(Within 2 weeks after discharge), 3month, 6month |
|
Secondary Outcome(s) 5 | ||
Outcome | Maximal tidal volume |
|
Timepoint | Baseline(Within 2 weeks after discharge), 3month, 6month |
|
Secondary Outcome(s) 6 | ||
Outcome | Maximal oxygen pulse |
|
Timepoint | Baseline(Within 2 weeks after discharge), 3month, 6month |
|
Secondary Outcome(s) 7 | ||
Outcome | VE/VCO2max |
|
Timepoint | Baseline(Within 2 weeks after discharge), 3month, 6month |
11. Study Results and Publication
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
---|
TOP
BOTTOM
화면 최하단으로 이동